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With Narrowed Focus, Elcelyx Prepares for Diabetes Drug Trial

8 hours 56 min ago
Bruce V. Bigelow

For San Diego’s Elcelyx Therapeutics, 2014 may someday be remembered as “the year of heavy lifting.”

Since the fall of 2013, when Elcelyx spun out NaZura BioHealth as a sister company with the same management (focused on commercializing a dietary ingredient called Lovidia), the company has crossed off a variety of accomplishments that include:

—Selling NaZura BioHealth about a year ago in a deal that has not been previously disclosed. Elcelyx CEO Alain Baron said Elcelyx pocketed some proceeds from the sale, although he declined to provide details.

—Completing mid-stage clinical trials of Elcelyx’s drug candidate, a proprietary oral compound for patients with type 2 diabetes who cannot tolerate metformin, the first-line drug of choice for most of them.

—Securing about $6 million in funding last month from existing investors Morganthaler Ventures, Kleiner Perkins Caufield & Byers, Technology Partners, and GSM Fund. Including the latest funding, Baron said Elcelyx has raised a total of roughly $57 million over the past five years.

—Concluding what Baron described as “a protracted, but ultimately very productive conversation with the FDA” that has positioned Elcelyx for a final push in the development of its drug candidate.

“We’ve agreed on a path forward, and agreed on the studies we need to do,” Baron told me this week. “We’re confident that this is something we can do.”

Alain Baron

Now Elcelyx is developing specific protocols for carrying out three late-stage studies that would involve a total of 1,500 to 2,000 patients—and considering the best way to fund them. Baron estimated the cost of completing Phase 3 trials would be almost $100 million.

Baron is not yet sure how the company will fund the late-stage trials, but he sees three options for the company: raising capital through an IPO; selling Elcelyx and its drug program to a pharmaceutical company with the wherewithal to complete the trials, or remaining private and raising enough capital for Elcelyx to carry out the late-stage trials itself.

Elcelyx was founded in 2010 with initial support from Morgenthaler Ventures, where Baron was an entrepreneur-in-residence.

From the beginning, the company had a … Next Page »

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“Voice for Everyone”—Life-Sci Women Talk Venture, Pharma Gender Gap

Wed, 03/04/2015 - 19:55
Alex Lash

By the numbers, the rare-disease drug developer Raptor Pharmaceutical (NASDAQ: RPTP) recently upped its chances of better market performance.

That’s because biopharma veteran Julie Anne Smith (pictured) on Jan. 1 officially took the helm of the Novato, CA-based biotech firm from Christopher Starr, and time and again, studies show that companies with more women in top positions post better results. The most recent study, from investment bank Credit Suisse, came out last year.

But it’s no secret that companies of all stripes, not just in the life sciences, are slow to get the message. In a discussion Tuesday at the CalBio conference in San Francisco, Smith and three other women with decades of experience in the life science business talked about how to close the gender gap, while sharing some of their management styles and career frustrations.

One business that has actually regressed in its gender balance is venture capital. During the discussion yesterday, Wende Hutton, a general partner at Canaan Partners and 20-year life science venture veteran, called her industry “a bastion of male clubbiness.”

A Babson College study released last year showed just 6 percent of venture partners globally were women. (This is across all venture, not just life sciences.) That figure is worse than in 1999, when it hit 10 percent. “Times don’t change much,” said discussion moderator Lisa Suennen, who from 1998 until last year was a healthcare investor and partner at Bay Area firm Psilos Group.

One venture figure related to women has shown some improvement. About 15 percent of U.S. businesses receiving venture capital have at least one female executive, up from 5 percent in 1999, according to the Babson report. (But fewer than 3 percent of U.S. companies receiving venture dollars have a woman as chief executive.)

Hutton said one of her best mechanisms for coping with the men’s club was turning 40. “Maturity was a great thing for me,” she said, as she learned “to distance myself” from the frustrations as well as “to be really, really direct.”

Hutton said having more women on board—two of eight general partners in Canaan’s latest diversified fund are women—steers the firm’s culture toward inclusiveness. “When there’s a voice for everyone, better decisions are made,” she said, and she also made the case that it’s a competitive advantage.

Hutton: Be direct.

With more female founders and CEOs in the life sciences, Canaan has won deals because they have walked into a meeting with Canaan “and they see different faces around the table, not just 45- to 60-year-old white men.”

(Hutton declined to give specific examples, but she did point out that Canaan has 13 current portfolio companies with women CEOs.)

Also on the panel was Magda Marquet, a biotech fixture in San Diego who cofounded diagnostics maker AltheaDx. Marquet seconded the notion that women in top roles can shift a company’s modus operandi, calling it “living with integrity.”

Raptor’s Smith told the room that simply being in the corner office or in a board seat isn’t enough. Women executives need to make it clear that corporate culture is changing. Smith, who was executive VP of strategy and chief commercial officer at Raptor for more than two years until her promotion, said she tries to be a mentor for younger women, but that men in junior positions have picked up the signal and also come to her for advice. (One man, however, called her a “socialist” for trying to instill a more egalitarian culture, she said.)

Prospective employees also get a signal that Raptor, which markets a drug to treat the rare nephropathic cystinosis and has several more in development, has a different culture. Smith said her favorite interview question for men … Next Page »

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Grid2Home Changes Name to Kitu Systems, Raises $2.3M from Investors

Wed, 03/04/2015 - 02:40
Bruce V. Bigelow

San Diego-based Grid2Home, founded in 2009 to develop software for the emerging market in smart meter data communications, has changed its name to Kitu Systems, apparently to position the company for the broader market in the “Internet of Things.” The company explains on its website that “Kitu” means “thing” in Swahili.

Kitu Systems also has raised another $2.3 million from investors, according to a recent regulatory filing, which brings total funding for the company to at least $11 million over the past six years.

No explanation was immediately available for the change. An executive at Kitu’s San Diego headquarters said Monday that CEO Rick Kornfeld was out of town, and Kornfeld did not respond to an e-mail query from Xconomy.

The company is still focused on smart meter and smart grid applications intended to help home-owners monitor and manage their home energy efficiency, and to manage their photovoltaic solar systems, electric vehicle charging systems, and related industrial applications.

But according to the company’s new website, the Internet of Things market has changed significantly over the past six years. So Kitu Systems has expanded its target market accordingly, saying, “Kitu Systems provides robust and scalable software for the Internet of Things. Kitu’s software enables secure and reliable communications from the Thing to the Cloud over a variety of wired and wireless networks.”

The company says its customers include big companies, smart device manufacturers, semiconductor manufacturers, and automotive companies.

As we reported some time ago, the company was co-founded by CTO Don Sturek and CEO Mike Bourton. Sturek apparently left Kitu Systems, and has been working at Silver Springs Network since last summer, according to his LinkedIn profile. Bourton, a longtime telecom executive, continues to serve as Kitu’s vice president of business development.

Granite Ventures managing director Sam Kingsland remains on Kitu Systems board, and former Texas Instruments executive Doug Rasor still serves as chairman.

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Under New Initiative, Biocom Scouts for Strategic Partners in Japan

Tue, 03/03/2015 - 16:40
Bruce V. Bigelow

After working for years to make inroads in China, San Diego’s Biocom industry group has refocused its global partnering efforts on a new initiative intended to connect emerging life sciences companies in San Diego with big pharmas in Japan.

Biocom and the Japan Bioindustry Association signed a formal partnership agreement last summer, according to Biocom CEO Joe Panetta. At least 10 Japanese companies also have joined Biocom, which now counts about 800 life sciences companies as members, primarily in San Diego and Orange counties.

“We are not a large organization, and we have to choose our opportunities carefully,” Panetta recently told me. Biocom focused on developing life sciences partnerships in China from 2009 to 2013, and Panetta said he came to the conclusion that it wasn’t a good fit for the small and mid-size companies that make up most of San Diego’s life sciences sector.

Some Japanese pharmas already have established outposts in San Diego. In September, Daiichi Sankyo acquired San Diego’s Ambit Biosciences and its drug for acute myeloid leukemia for as much as $410 million. In 2013, Japanese specialty chemical and pharmaceutical maker Ajinomoto acquired San Diego contract drug manufacturer Althea Technologies for $175 million. In 2012, Takeda closed its operation in South San Francisco and expanded its San Diego center of excellence.

Generally speaking, however, “In Japan, they still think of Boston and San Francisco as the center for life sciences in the United States,” said Jiro “Tony” Fujita, who was hired last year to lead Biocom’s Japanese initiative. But Fujita sees interesting partnership opportunities for the San Diego  companies focused on drug development, regenerative medicine, and digital health.

“In the 1980s and 1990s, there was a boon to create more [life sciences] startups in Japan,” Fujita said. “But they didn’t get the funding, because Japanese VC is almost like banks. The [startups] could only get funding if it was a deal that could not fail.”

With many drug patents expiring, “We recognize that the pharma industry in Japan has a need for products,” Panetta said. In his view, the biopharma companies on the East Coast are more inclined to create partnerships with Europe, which means San Diego companies have a better chance for striking deals in Japan, Singapore, South Korea, and other Asian countries.

As an industry group, Biocom has been identifying U.S. companies with knowledge of Japan’s Ministry of Health & Welfare and its regulatory requirements for drug development. “We also signed an agreement with the technology transfer office at University of Nagoya, which allows them to introduce some of their early-stage technologies to San Diego for regulatory advancement,” Panetta said. “This takes advantage of what we know to move their products.”

Japanese companies are also interested in home health care, which represents a good opportunity for San Diego’s emerging cluster of wireless health startups, Panetta said.

“In Japan, everybody is thinking [about] how to break through in new markets,” Hironori Tanaka of Japan’s Bioindustry Association told me last week at Biocom’s global life science partnering conference in San Diego. Japan’s prime minister, Shinzō Abe, “clearly pointed out future Japanese strengths, and biotech is a main sector.”

“My job as coordinator is to bring new technology to industry,” Tanaka added, “and San Diego is unique. Our cooperation with Biocom makes sense in Japan.”

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Tiger Teams, Dropping Subs, and Biotech’s Elusive Second Strikes

Tue, 03/03/2015 - 08:30
Alex Lash

Onesie-twosie? Double dipping? The old razzle dazzle? Whatever you call it, it’s a rare feat to sell a biotech company, hold something back to start a new company, then ride that second horse to success.

The team behind Flexus Biosciences is halfway there, as I wrote about last week. They sold a preclinical cancer immunotherapy research program to Bristol-Myers Squibb (NYSE: BMY) for $800 million upfront, but held onto other assets: a cancer drug about to enter the clinic and another research program centered upon a type of immune cell. With all that, the same investors and executives expect to form a new company.

“We wanted to build Flexus for the long term,” said Flexus CEO Terry Rosen. “It never crossed my mind to do this. Retrospectively it might look strategic, but you could hook me up to a lie detector—it was just a set of circumstances.”

As the as-yet-unnamed Flexus sequel cranks up and looks to land the rare one-two punch, Rosen and team can take heart that at least two investors have previously pulled off the trick. The Column Group and Topspin Partners were part of the syndicate that joined San Diego biotech veteran Richard Heyman in successive startups Aragon Pharmaceuticals and Seragon Pharmaceuticals, as my colleague Bruce Bigelow documents here.

Heyman: Buy, spin.

In 2013 Heyman and his backers sold Aragon and its prostate cancer drug to Johnson & Johnson (NYSE: JNJ) for up to $1 billion but kept a breast cancer program. Seragon, formed around that candidate, was bought by Roche’s Genentech division last year for up to $1.7 billion.

“We made the strategic decision not to partner too early,” says Heyman. “That limits your options.”

Soon after they sat down with J&J to discuss Aragon, it was clear the primary target was the prostate cancer drug. Both sides soon began to talk about a hold-back—what Heyman prefers to call a “buy-spin” scenario—even though “we knew the lawyers would have field day,” he says.

Buyers who don’t mind the headache are obviously important. Heyman credits Tao Fu, the head of M&A at J&J who went on to the same role at Bristol-Myers, shepherding the acquisitions of Flexus and iPierian (I’ll get to that in a moment).

With Aragon, the parties had to simultaneously craft four contracts. “Our heads were spinning, and we had conversations to say ‘Shoot, let’s sell the whole company and just have one contract,’” says Heyman.

With Aragon dissolved and its prostate cancer drug in J&J’s hands, Seragon emerged within a few days with most of Aragon’s employees, its breast cancer program, and a $30 million check from the Aragon syndicate. A board member said right away there would be no intention the second time around to sell Seragon, says Heyman. (Genentech bought it nine months later.)

One call Heyman received in the subsequent months was from Terry Rosen. “He wanted me to walk him through my deal,” says Heyman. “I was happy to do it.”

Another Flexus investor with buy-spin experience is Beth Seidenberg of Kleiner Perkins Caufield & Byers. Seidenberg wasn’t involved in Aragon/Seragon, and she has yet to land that elusive exit-begets-exit. But she has a term to describe small management groups of people like Heyman who are tailor-made for exactly these opportunities: Tiger teams.

Seidenberg: Tigers wanted.

Her impetus to watch for buy-spin opportunities (she’s not a fan of the term “double dipping”) came from a lost opportunity. She was chairman of Arresto Biosciences, a Redwood City, CA-based biotech that Gilead Sciences (NASDAQ: GILD) bought in 2010 for $225 million plus milestones.

The lead compound, for idiopathic pulmonary fibrosis, was in Phase 1, and Seidenberg says a second program was less than a year behind. “We could get no value for the second program,” she says. “They only valued the company on the first asset.”

But Gilead said it wanted to keep the second asset. Seidenberg and Arresto CEO Peter Van Vlasselaer didn’t push back hard, fearing “we would have blown up … Next Page »

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Finistere Raises $150M for New Fund Focused on Agricultural Biotech

Mon, 03/02/2015 - 15:01
Bruce V. Bigelow

Finistere Ventures, a San Diego investment firm focused on agricultural biotechnology, said it has closed on $150 million for its second fund.

In a regulatory filing, the firm indicates plans to raise as much as $200 million for the fund, Finistere Ventures II. In a separate filing, Finistere disclosed plans to raise $20 million for a related feeder fund.

Amid challenges that include decreasing agricultural land resources, climate change, and changing population demographics, Finistere said it is collaborating with Bayer CropScience, Calgary-based AVAC, and other global partners to invest in new technology solutions in food productivity, sustainability, and nutrition.

In addition to its San Diego headquarters, where the firm began investing in 2005, Finistere also has added an office in Palo Alto, CA, headed by former Venrock vice president Spencer Maughan.

“Silicon Valley has become a major hub for new agtech companies, and a more diverse group of investors,” Maughan says in the statement from Finistere. “With California as the leading agricultural state by value and the biggest concentration of venture investing in the world, the prospects for investment in Agtech are ideal.”

The firm says its investments will be focused primarily in North America, but it is also working with partners in Australia, New Zealand, and Israel.

In a statement, Finistere chairman Jerry Caulder, says, “The timing for a new fund coincides with the new wave of innovation needed to create the next Green Revolution in agriculture. By partnering with the expanding VC interest, we can build on the positive results we’ve had in this sector.”

In its first fund, Finistere invested in both agricultural biotechnology and healthcare startups, including San Diego-based ZeaKal and SG Biofuels; Campbell, CA-based Sadra Medical; Menlo Park, CA-based Transcend Medical; and Morrisville, NC-based nContact Surgical.

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Cancer Immunotherapy Companies: Looking Forward and Looking Back

Mon, 03/02/2015 - 05:00
Stewart Lyman

I’ve been researching one of our local immunotherapy developers here in Seattle, trying to round up the views of industry experts regarding the future prospects of a drug at the front of its pipeline. Do they think it’s a good investment? Here’s what I found out:

Analysts predict that sales of its first drug will peak at $2 to $3 billion per year.

The company’s “strong data will give [it] the upper hand in any negotiations with potential pharmaceutical partners interested in the drug.”

Its share price jumped 27 percent on the day of its IPO.

Its drug has “proved to be highly effective in late-stage clinical trials.”

A competing immunotherapy drug (that analysts were worried would take significant market share) was abandoned by the companies trying to develop it.

Sounds pretty darn promising! Where do I send my money?

There’s only one problem. The company I’m referring to is not high-flying Juno Therapeutics (NASDAQ: JUNO). It was Dendreon, which declared bankruptcy in November in the face of a crushing $660 million debt load and weak sales of its prostate cancer drug, sipuleucel-T (Provenge), the subject of the quotes above. The stock, which reached a high of $57.67 in 2010, traded down to 13 cents after Dendreon entered Chapter 11.

This was only a little over four years after the company received FDA approval for its first and only drug. Dendreon’s assets were sold off for $495 million a few weeks ago to Valeant Pharmaceuticals (NYSE: VRX). Although some forty organizations looked through Dendreon’s books, the dearth of bids suggests that most pharma companies thought it would be too difficult to bring sipuleucel-T to profitability. Dendreon’s workforce has shrunk to a small fraction of what it was only a few years ago. Shareholders are likely to be completely wiped out in the bankruptcy.

The problems that Dendreon ran into have been widely recounted, but here’s a short summary:

Sipuleucel-T was considered by many to be only marginally effective, especially for the $93,000 the company was charging for it. Men treated with the drug lived only about four months longer than men in the control arm of Dendreon’s key clinical trial.

The novel nature of this treatment (made by isolating each patient’s white blood cells, incubating them in a lab with immune system stimulatory proteins, and then reinfusing them back into the patient) meant that significant money would need to be spent educating doctors on its use. It also meant that manufacturing costs for the drug would be extraordinarily high. It’s still not clear how much the company was able to do to reduce this expense since sipuleucel-T first came on the market in April 2010.

Two competing drugs (enzalutamide, sold as Xtandi; and abiraterone acetate, sold as Zytiga) came on the market two years after sipuleucel-T was approved. They were each about as effective as Dendreon’s drug and were cheaper and easier to administer (once-a-day pills instead of doctor office infusions).

Sipuleucel-T had a high “cost density” that required doctors prescribing it to lay out $93,000 to purchase this treatment for each patient, then (hopefully) get reimbursed by insurers.

Overall, the expense, marketing and reimbursement issues, limited benefit, and complicated manufacturing process greatly inhibited sipuleucel-T’s acceptance by doctors.

Dendreon proved to be a stock speculator’s dream, with market machinations and accusations that insiders profited from stock sales when they had known that sipuleucel-T sales would not meet the expectations that they had publicly laid out. Some business school is bound to do a full business case study on Dendreon, if it hasn’t been done already.

What about Juno?

I’m hopeful that Juno will succeed in a field where Dendreon ultimately failed for three reasons:

1) Patients will benefit greatly if its treatment is truly effective against cancer, and its T-cell based technology is very powerful. This is not a retooling of some older cancer therapy, but is a new approach that has significant clinical promise based on early data.

2) The company may grow substantially here in Seattle, helping to rebuild a biotech cluster that has been diminished by numerous acquisitions (Immunex, Corixa, Icos, and ZymoGenetics), departures (Amgen, the Bristol-Myers Pharmaceutical Research Institute), and failures (Dendreon, VLST, Allozyne, and Novo Nordisk’s inflammation group) of local companies. A good sign: Juno recently leased a manufacturing site in Bothell, WA.

3) A number of people that I’ve worked with over the years and respect are employed there, and I’d love to see them achieve great success.

What scientific, legal, and business challenges does Juno (and, for that matter, many of the other immunotherapy companies that it is competing against) face?

1) Intellectual property concerns. Juno is already embroiled in legal proceedings with the Novartis-backed group at the University of Pennsylvania. Juno licensed some of its IP from St. Jude’s Children’s Research Hospital, which is suing the UPenn group for breaching an agreement over the use of its T-cell technology. I have no idea which group has a stronger position or how this will play out, although it’s safe to say that the lawyers on both sides will be handsomely recompensed. My best guess is that there will be a cross licensing of IP between these organizations. Getting shut out of the market would be fatal.

Seattle biotech veterans have already seen this scenario play out. Years ago we had a local company, CellPro, who’s only product, the Ceprate column (used to purify stem cells from blood), won FDA approval in 1996. Unfortunately, a larger and stronger company with deep pockets and a strong patent challenged legal claims to the technology that were at the heart of CellPro’s product. Despite confident pronouncements in its position, CellPro … Next Page »

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Innovation Hub: Advertising’s New Age

Sat, 02/28/2015 - 02:01
Kara Miller

A product, a camera phone, and a sensor. Those may be the essential tools of advertising in the 21st century.

Increasingly, we’re witnessing the disappearance of the classic, 30-second ad. Now products are looking to lure us with humor (I’m looking at you, Old Spice Guy) or whiz-bang theatrics (think Jean-Claude Van Damme straddling Volvos). Or they’re just hoping to track our every move with sensors, so they know the clothes, medicine, and cars that would be perfect for us.

I spoke about this new advertising landscape with James Percelay, co-founder of Thinkmodo and the king of viral videos (like this devil baby spoof with 50 million hits on YouTube), and Edward Boches, veteran of the ad agency Mullen and now a professor at Boston University.

[This interview has been edited and condensed. For the full conversation, visit innovationhub.org.]

Kara Miller: We know that lots of people avoid ads. So if you’re an advertiser, what do you do?

Edward Boches: The real future of advertising is going to be much less message-based and much less storytelling. It’s going to be more into the world of utility, data, and sensor-based feedback that will help marketers create useful applications or experiences that will actually benefit consumers.

KM: What do you see that has worked and broken through the clutter?

James Percelay: Earned media is the name of the game. For example, Volvo had an extraordinary campaign last year for Volvo trucks. They featured Jean-Claude Van Damme doing a split between two parallel trucks, which were going down the highway. It was Volvo’s way of showing the dynamic steering capabilities of these trucks. It was engaging and surprising, and it really drew people to this product.

EB: And the Volvo video never ran as a television commercial. It only ran online. It’s interesting because all these media properties have to fill up with content, and they want to be one of the first ones, not the last ones. It’s actually pretty easy to generate PR coverage for these kinds of ideas.

KM: How important is the role of celebrity? I always think of celebrities as very helpful in selling products.

JP: I think you are overestimating the role of celebrity. We are all potential celebrities now. Viral videos are as much content-driven as celebrity-driven, and if you create something amazing, people will share it. The new breed of celebrities are YouTube celebrities and online influencers.

KM: Can you point to companies that are doing interesting and unusual things with their advertising budgets?

EB: The new influences on advertising are not coming from the media world; they’re coming from the technology world. They’re coming out of Silicon Valley. It’s a one-to-one relationship and an exchange between the consumer and the brand.

The Under Armour brand now has sensors in all of their products, and they do a tie in with Zappos. So if you buy a pair of sneakers on Zappos, the sensor will identify when it’s time to buy a new pair. And you’ll get a nice e-mail notifying you that it’s time to buy a new pair of sneakers.

KM: Can you tell us an ad campaign that you have not worked on that is really interesting to you right now?

JP: It’s pretty obvious, but pretty incredible when you think about it. And that would be Apple, Inc. Apple has reached the status of being the biggest corporation on the planet. Yet, they have a mantra that you can be empowered with their equipment, and you can excel in every aspect of your life using their technology. They’re a company that empowers its users and gives them the tools for expression and creativity.

Tricia Breton contributed to this write-up.

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Milestones of Innovation 3: ‘Modern Pioneers’ at the Waldorf–1940

Fri, 02/27/2015 - 08:00
Victor McElheny

When people made lists of leading innovators 75 years ago, they saw a landscape very different from today’s for putting discoveries, techniques, money, workers, and customers together to get something new and useful onto the market. In the brief interval between the Depression and World War II, the dominant factor was the large, vertically integrated corporation able to use retained earnings to finance its own scale-up to mass-marketing of cars, light bulbs, and plastics.

On the evening of Feb. 27, 1940, a lot of high-powered Americans gathered at the Waldorf-Astoria Hotel in New York to honor the nation’s top innovators of the previous 25 years. Those who had done the most to advance “the American standard of living” were designated “Modern Pioneers.” Each received a special plaque depicting factories, dynamos, laboratory flasks, and airplanes thrusting aside the ox and the covered wagon.

The 1,500 at the Waldorf were celebrating the impending  150th anniversary of the first United States patent law of April 10, 1790.  The not-so-hidden agenda behind the banquet was to combat the notion, widely held in the Depression, that new technology was a job-killer, and to build sentiment against changing patent practices to encourage non-exclusive licensing (as the New Deal Anti-Trust Division advocated).

The event had quite a buildup. The principal sponsor, the National Association of Manufacturers (NAM), recruited a prestigious jury to pick the Pioneers, headed by MIT President Karl Compton. They winnowed 1,000 nominees down to 572 who were honored at some 15 regional dinners, including a bash at Boston’s Copley Plaza Feb. 18.

All those honored were men, and all were individuals except 10 members of the DuPont team that developed nylon. Its leader, Wallace Carothers, had committed suicide three years earlier. Other Pioneers, such as Lee DeForest of the Audion triode tube, Henry Ford of the automobile assembly line, and Orville Wright of the airplane, were also absent. The Belgian immigrant Leo Baekeland of Bakelite was represented by his son. Charles Kettering, inventor of the automobile self-starter and the legendary “boss” of General Motors research, addressed the banqueters by telephone from his laboratory in Coral Gables, FL. His theme was, “Pioneering never ceases.” Kettering said, “We have only scratched the surface of invention… America is not yet finished.”

The youngest of the national winners, 30-year-old Edwin Land of Polaroid Corporation, stood beaming in the center of the front row of the Waldorf group picture, next to x-ray developer William D. Coolidge, boss of GE’s research, who had tried to hire Land years before. Land’s invention of inexpensive plastic light-polarizing sheet was already used in many pairs of sunglasses; it was being tested for use in all automobiles to cut nighttime highway glare.

Others in the front row were Vladimir Zworykin, inventor of RCA’s television tube; Irving Langmuir of GE, developer of a more efficient incandescent light bulb; Willis Carrier of air conditioning fame; George Curme of Carbide and Carbon, inventor of Prestone anti-freeze; and Harry Steenbock of the University of Wisconsin, who found a way to add Vitamin D to milk. In the back row, looking glum, was Edwin H. Armstrong, inventor of the circuitry behind commercial two-knob radios as well as FM.

The occasion couldn’t banish larger issues entirely. Dictatorships in Europe and Asia had launched World War II. And American unemployment, while declining, was still huge. On Jan. 3, 1940, President Franklin Roosevelt told Congress, “We have not yet found a way to employ the surplus of our labor which the efficiency of our industrial processes has created.” He added, “To face the task of finding jobs faster than invention can take them away is not defeatism.”

NAM president H.W. Prentis was indignant. He told the banqueters that from 1870 to 1930 (tactfully omitting the Depression), U.S. production increased 11-fold, while employment nearly quadrupled. “Did invention take away jobs faster than other jobs could be found in those years? Obviously not. Moreover, employment today is most nearly normal in those industries that are most highly mechanized—on which there has been the greatest technological advance.”

Few at the Waldorf could have known how quickly the task of defeating the dictators would bring industry together with government and lead to the greatest private-public partnership in history.

[Editor’s Note: This is the third of an ongoing series of posts about the history of the history of key technologies. You’re invited to suggest other milestones of innovation for in the Xconomy Forum. Example: This year will mark the 150th anniversary of Alexander Holley’s pilot plant in Troy, New York, for making steel by the Bessemer process.]

Further reading:

Victor K. McElheny, Insisting on the Impossible: The Life of Edwin Land, Inventor of Instant Photography, Perseus Books, 1998.

“Trade is Defended in ‘Labor Surplus,’ “ New York Times, Feb. 28, 1940.

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3D Robotics Raises $50M To Develop Mobile-Enhanced Drones

Thu, 02/26/2015 - 20:17
Bernadette Tansey

Berkeley, CA-based 3D Robotics has raised $50 million in a Series C funding round led by Qualcomm, the San Diego wireless industry giant.

The two companies plan to work together to combine 3D Robotics’ drones with Qualcomm’s Snapdragon processors, which power sensors, wireless communication, and cameras.

“By working with Qualcomm Technologies, Inc., we can bring advanced computing to the skies at an increasing pace,” said Chris Anderson, CEO of 3D Robotics in a statement. “Such multi-gigahertz Linux-based onboard computing platforms, combined with state-of-the-art cameras and other sensors and wireless technologies, will allow us to create next-gen drones that are smarter, easier and safer than ever before.”

Earlier this month, San Diego-based Qualcomm (NASDAQ: QCOM) acquired KMel Robotics, a Philadelphia, PA-based startup that makes high-performance multi-rotor drones.

The 3D Robotics funding announcement follows a recent proposal by the U.S. Department of Transportation’s Federal Aviation Administration to “accommodate future technological innovations” by accepting the routine use of small unmanned aircraft systems under 4.4 pounds flying lower than an altitude of 500 feet, and at speeds no greater than 100 miles per hour. People over 17 years old who have obtained an FAA operator certificate could fly these drones. Under the proposal, the operator would not be required to obtain a private pilot’s license. The proposal is open for public comment pending a final decision.

According to a 3D Robotics statement announcing the new capital infusion, the FAA proposal would “stimulate a huge amount of drone innovation by allowing the industry to advance at the pace of smartphones, not airplanes. This means drones that are smaller, cheaper, lighter, safer and in the hands of more users, finding more uses than ever before.”

Among 3D Robotics’ products is the IRIS+ personal drone, (pictured above) which can be used with GoPro cameras for aerial photography.

3D Robotics was founded in 2009 by Chris Anderson, former editor-in-chief of Wired Magazine and founder of DIYDrones.com, and Jordi Muñoz, who was building his own drones in southern California and met Anderson through the DIYDrones online community. Muñoz, born and raised in Mexico, is now chief technology officer at 3D Robotics, which operates a manufacturing facility in Tijuana, Mexico. The company also has offices in San Diego, CA, and Austin, TX.

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West Coast Biotech Roundup: Flexus, NGM, Illumina, Bob Klein & More

Thu, 02/26/2015 - 16:25
Alex Lash

A few West Coast companies made news back east this week at the Advances in Genome Biology and Technology conference in Florida, while others (Flexus Biosciences, NGM Biotherapeutics) stayed home to count hundreds of millions of dollars rolling in from huge deals. But the biggest number of the week—$100 billion—came from the mouth of California stem cell fundraiser Bob Klein. To find out what Klein was talking about, and for a lot more news, let’s get to the roundup.

—Flexus Biosciences of San Carlos, CA, was acquired by Bristol-Myers Squibb (NYSE: BMY) for $800 million guaranteed and $450 million more in milestones. Announced Monday, BMS acquired Flexus’s cancer immunotherapy program—considered a prime candidate for combination treatments—but left significant assets behind, which Flexus’s management and investors expect to spin out into a new unnamed company.

—NGM Biotherapeutics of South San Francisco, CA, said Monday it had struck a lucrative partnership with Merck that will feed NGM’s metabolic drug candidates into Merck’s pipeline. NGM receives $200 million immediately and $250 million in R&D subsidies over five years. Part of that cash buys Merck a 15 percent stake in NGM.

—South San Francisco’s Rigel Pharmaceuticals (NYSE: RIGL) also hooked up with BMS, sealing a $30 million guarantee to work together on cancer drugs that target TGF beta, which tumor cells use to suppress the immune system. Rigel could earn more than $309 million in future milestones.

—Relypsa (NASDAQ: RLYP) of Redwood City, CA, sold 3.9 million shares at $38.50 a share on Wednesday to raise about $150 million. Underwriters have the option to buy up to 585,000 additional shares.

—Illumina (NASDAQ: ILMN) said Thursday that its San Francisco-based accelerator has received $40 million from Viking Global Investors to seed its “Boost Capital” fund. The Boost cash will provide matching funding to its graduates that raise between $1 million and $5 million.

—Bayer Healthcare also has a farm-system program in San Francisco. In a deal announced Tuesday, its CoLaborator incubator tenant Aronora will work with Bayer on preclinical manufacturing of its cardiovascular drug AB-022.

— At the AGBT conference, 10x Genomics of Pleasanton, CA, unveiled its GemCode platform, which allows analysis of “long read” genetic sequences using a “short read” Illumina sequencer. Xconomy reported on the company’s emergence from stealth in January.

—Also at AGBT, Maverix Biomics of San Mateo, CA, debuted its Maverix Complete next-generation sequencing platform.

—Theravance Biopharma (NASDAQ: TBPH) of South San Francisco has begun a Phase 3 trial of its antibiotic telavancin (Vibativ) in patients with staph infections that have reached the bloodstream.

—Shire (NASDAQ: SHPG) paid $70 million upfront and $175 million in milestone payments to acquire Meritage Pharma of San Diego and its orphan drug for treating a rare condition known as eosinophilic esophagitis (EoE).

—Bob Klein, who led the 2004 campaign that created the California Institute for Regenerative Medicine and provided $3 billion for stem cell research, is promoting a $100 billion international bond program to speed R&D of new therapies in stem cells and genomics. Klein outlined his idea at the UC San Diego Moores Cancer Center last week, according to a report by Brad Fikes of U-T San Diego.

—San Diego-based Cebix, founded in 2008 to develop a replacement peptide for diabetes-related microvascular problems, shut down last month after a mid-stage clinical trial failed. The company raised at least $50 million from venture investors including Thomas McNerney, InterWest Partners, and Sofinnova Ventures.

—Neurocrine Biosciences (NASDAQ: NBIX) closed out a secondary stock offering, with underwriters boosting the total funds raised to $287 million.

—Longtime San Diego pharmaceutical executive Richard Hollis plans to debut on March 13 a new e-commerce startup at the South by Southwest Interactive conference in Austin, TX. The 62-year-old biotech executive said he started working on San Diego-based Holonis soon after he was ousted from his namesake company, Hollis-Eden Pharmaceuticals.

—San Diego-based Sotera Wireless said it acquired Reflectance Medical, a four-year-old startup in Westborough, MA, with sensor technology that monitors critically ill patients, including those with traumatic injuries. The company’s FDA-cleared sensors go beyond the scope of standard vital signs to continuously monitor microvascular oxygen, pH, and hemacrit. No financial terms were disclosed.

—Seattle’s Juno Therapeutics has rewarded top executives with big bonuses, with CEO Hans Bishop doubling his base salary, according to the Puget Sound Business Journal.

—In a spate of news from the AGBT conference, Spiral Genetics of Seattle said it had launched new products and begun collaborations with Stanford University and the U.S. Department of Energy.

Xconomy San Diego editor Bruce Bigelow contributed to this report.

 

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To Manage a Successful Sports Team, Focus on Data

Wed, 02/25/2015 - 13:57
Ben Shields

The mantra of youth sports where “everyone gets a trophy” is permeating professional leagues. These days every team can claim some semblance of winning. In the bygone era of the NFL, two teams made the playoffs and that consisted of one game, the Super Bowl. Today six teams from each conference advance, and there is talk of adding more. In MLB, it used to be that the league leaders won the pennant and then went to the World Series; now, five teams in each league make the playoffs. In the NBA and the NHL, meanwhile, more than half of all teams make the post-season.

As the definition of post-season success broadens and winning becomes a commodity, a team’s performance isn’t enough to stand out in the $750 billion sports industry. And at a time where traditional revenue streams are under pressure and the competition for money, media, and sponsors remains stiff, sports organizations have to be more innovative.

So, what should they be doing to drive revenue? How can they use technology to attract and interact with fans? And, in the Age of Big Data, what’s the best use of analytics to increase ticket sales? These are some of the questions on the table at the 2015 MIT Sloan Sports Analytics Conference.

There are a variety of ways the sports industry is using data analytics to solve problems and make better decisions. Many are familiar with how general managers and coaches on the player personnel side of teams have increasingly used data to gain a competitive edge on the field or court. (Think Moneyball.) Their goal, of course, is to boost team performance. In layman’s terms: win more.

Successful leaders on the business side of sports teams are also capitalizing on data analytics. Their goal—counterintuitive as it sounds—is to build stable businesses that do not depend too much on winning to grow. Here is what the most inventive teams are doing from a business perspective:

Using data analytics to power ticket sales. I am moderating a panel that will examine how teams and ticketing agencies use Big Data and social media to find fans online. We will look at which avenues present the best ways of finding and interacting with fans, as well as what these digital activities mean in terms of ticket sales.

Some teams, of course, already use data to analyze fan behavior and spending to drive revenue. The New England Patriots and the Red Sox, for instance, use dynamic ticket pricing—similar to what the airlines do—to charge differently for games based on supply and demand. Mobile technology also opens up additional revenue opportunities. The Golden State Warriors’ mobile application offers “proximity-based” deals on seat upgrades and merchandise that are tailored to where fans are located in the arena. As more fans interact with teams through mobile platforms, the amount of consumer data will only increase, incentivizing teams to create better products and services for fans.

Maximizing social media to connect with fans. Successful sports organizations have become media companies themselves. The L.A. Lakers are a prime example. The franchise employs an in-house digital team charged with creating and distributing content in a reality show format through Facebook, Twitter, Instagram, and Vine. The content streams even in the off-season, which allows fans to feel like they’re with the team up close and personal all year round. Meanwhile, the advent of Snapchat’s “Our Story” feature has opened up new possibilities for the sports industry. Whether at the Grove in Oxford, Mississippi, or the 16th hole at the PGA Tour’s Phoenix Open, fans at the event create “snaps” of the experience from their perspective, and Snapchat curates the best for all users to see. The result is a first-person, often entertaining account of what it’s like to be there in person. Social media in this case enhances the allure of attending a live event—which could drive an increase in ticket tales.

Forging a strong identity to enhance sponsorships. Today’s most successful teams have distinct personalities. The Dallas Cowboys, for example, are widely known as “America’s team,” a nickname coined in 1979 that has endured. And while the team has not been particularly successful on the field in recent years—its record over the past 20 seasons is 158-146—the Cowboys are the most valuable franchise in the NFL at $3.2 billion, according to Forbes. One reason is the Cowboys’ home field, AT&T Stadium, a national landmark befitting of the team’s assumed status as a cultural institution. Beyond the ten Cowboys home games each year, AT&T Stadium also hosts other major sports and entertainment events. Hundreds of thousands of people journey there each year just to tour the venue, which also includes a contemporary art collection. Couple this year-round activity with enhancements to the in-venue mobile experience, and the Cowboys now have more quality sponsorship inventory to sell and the tools to demonstrate return on investment. An estimated 200 sponsors pay to associate their brands with the team, resulting in more than $100 million in annual revenue for the Cowboys, the highest in the NFL.

Winning is still important, of course. If your team isn’t competitive, these strategies will be more difficult to implement successfully. But on the other hand, teams focused on winning at the expense of the business often run into trouble.

The successful sports organization of the future must be able to win as a business without necessarily winning on the field. Leaders across the industry are already using data and technology to position their organizations for success over the long term. As the business of sports evolves, following the creative and innovative solutions to off-the-field challenges will be a fascinating spectator sport unto itself.

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Shire Acquires Meritage Pharma in Deal Potentially Worth $245M

Tue, 02/24/2015 - 14:01
Bruce V. Bigelow

[Updated 2/24/15 6:10 pm. See below.] After acquiring ViroPharma last year in a $4.2 billion deal focused on Cinryze, the Irish pharmaceutical giant Shire says it is following through on a four-year-old option that Exton, PA-based ViroPharma held with San Diego’s Meritage Pharma.

In a statement today, Shire says it has acquired San Diego’s Meritage Pharma for $70 million upfront, with another $175 million contingent on meeting milestones in the development of a viscous oral drug for treating a rare esophageal condition that makes it difficult to swallow.

Meritage’s oral budesonide suspension (OBS) is ready for late-stage clinical trials, after the San Diego company reported in September that it reduced the inflammation and dysfunction in a mid-stage trial in adolescents and adults with eosinophilic esophagitis (EoE). The FDA already has granted orphan drug status to OBS for the treatment of patients with EoE.

The disease is comparable to the kind of intense, life-threatening inflammation of the windpipe that some people get with an allergic reaction to eating peanuts. With EoE, food can get stuck in the esophagus and needs to be removed in the emergency room. While EoE was a disease few people had heard of 20 years ago, the incidence has been rising in the general population, according to recent studies. Shire now estimates the prevalence of EoE in the U.S. at about 181,000 cases.

In today’s statement, Shire’s Head of Research and Development, Philip J. Vickers, says, “Shire’s pipeline and strategic focus on rare diseases is further strengthened with the acquisition of Meritage, which also complements our strong GI capabilities.”

Meritage has developed a proprietary viscous oral formulation of budesonide that is the consistency of molasses and designed to … Next Page »

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Simple Energy Flips Switch on E-Commerce Site for Utility Customers

Tue, 02/24/2015 - 12:00
Michael Davidson

Explaining how you can save money, and maybe the planet, by cutting energy consumption is simple. Getting people to change their behavior is not.

Simple Energy, a software company in Boulder, CO, has made solving that challenge its mission since it was founded in 2011, and now it has what it thinks is a powerful new tool.

Simple Energy today released new e-commerce software that will sell energy-efficient appliances and electronics from brands such as Nest, Samsung, and Philips. But Simple Enegy isn’t going it alone—it will work with retailers like Amazon and Best Buy to fulfill orders, and more importantly is working with utilities such as San Diego Gas and Electric and Xcel Energy, the utility that serves much of Colorado.

The relationship with utilities is key, Simple Energy co-founder and CEO Yoav Lurie said, because despite investing a considerable amount of resources into its e-commerce software, the startup isn’t transitioning to a company that sells smart thermostats, washing machines, and refrigerators. Instead, the new product is a step that expands on Simple Energy’s strategy of selling software to utilities that enables them to run energy savings campaigns and connect them with customers.

“We’ve been focused on how utilities engage their customers, primarily through outbound communication and utility Web portals and the customer experience,” Lurie said. “We still play an intermediary role between the utility and their customers. That hasn’t changed. This is an expansion of that.”

As an intermediary, Simple Energy’s job is to help utilities engage customers in ways that changes their behavior and gets them to use less energy. To do that, Simple Energy creates software that utilities can use to create customer portals that provide energy savings tips and use reward offers, social features, and games to influence customers’ behavior.

The software also helps utilities run micro-targeted marketing campaigns and analyze data about their customers. Since being founded in 2011, Simple Energy, which has about 60 employees, has raised $8 million, including a $6 million Series B round last year. Its investors include the Westly Group, Bullet Time Ventures, and Vision Ridge Partners.

From the outside, that seems very different than e-commerce. But then again, when is a customer more engaged than when they’re shopping for a product—and when might a utility be more useful than when it can provide concrete data that could save its customers money on a major purchase?

Like any e-commerce site, the Simple Energy Marketplace allows shoppers to research and compare products and prices. The difference is Simple Energy envisions the marketplace as a white-label service offered by partner utilities that’s integrated with their billing systems. That integration will allow Simple Energy to offer what could be its key advantages—the ability to offer shoppers accurate estimates of how much energy and money they could save for each item offered in the marketplace, and the ability to apply instant rebates at the point of sale.

Many appliances and electronics already come with stickers telling potential buyers how much the average user could save. But Lurie said that’s a very rough estimate and doesn’t take into account variables such as location, pricing tiers, or consumption patterns.

So what’s in it for utilities? A few things, according to Lurie, and they relate to trends that are shaking up an industry that still relies on a 100-year-old business model.

Government regulations now require many utilities to offer more energy efficiency and demand reduction programs, including rebates, and utility companies need their customers to participate. But customers have been slow to enroll in those programs.

“That’s been really hard for utilities. Every utility is spending millions of dollars, and collectively they’re spending billions of dollars, on rebates for products and services, and much of that money is being left on the table,” Lurie said. Simple Energy cites a report from the Nielsen Company that says less than 7 percent of customers use available rebates, leaving billions on the table.

“The reason customers are not taking advantage of it is because it’s really complicated,” he said. “We’ve streamlined the whole rebate process and made instant rebates for high-price items possible where they’ve never been possible before.”

Lurie said utilities also have economic reasons to be interested. While power companies always will make the bulk of their money with electricity, e-commerce gives them a potential new revenue source, both for selling products and for other services they could profit from.

Finally, there are the customer satisfaction, positive PR, and goodwill utilities could earn by offering environmentally friendly services and products to customers, Lurie said.

There is some evidence consumers are open to the idea of listening to advice from their utilities when it comes to buying appliances. In 2013, Accenture reported that 58 percent of customers wished utilities would make recommendations about energy-saving products.

While Lurie said the move to e-commerce isn’t a pivot for Simple Energy, it likely will be a big part of the company’s future. Simple Energy will continue to focus on its customer-engagement software, but Lurie noted the amount utilities spend on rebate programs is many times more than the millions they spend on engagement.

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Former Biotech CEO Richard Hollis Unveils Web Startup Holonis

Tue, 02/24/2015 - 11:55
Bruce V. Bigelow

Richard Hollis, who lost control of his namesake biotech company in 2009, is staging a comeback with the launch of San Diego-based Holonis, an online marketplace providing e-commerce software and services on a subscription basis for business customers.

While Hollis spent 30 years in the pharmaceutical industry, beginning in 1978 as a salesman with Baxter International, he’s now focused on the Web, saying he “fell in love with the opportunity that the Internet represents.”

In a statement today, Holonis says it is now accepting new users for the beta launch of its online marketplace, which integrates e-commerce with content publishing, search, social media, e-mail marketing, and analytics. The company says its target customers are the 28 million small and medium-sized businesses in the United States, and “nearly 50 percent of those businesses have no Web presence.”

Of course, the e-commerce market that Holonis is targeting is already dominated by some of the world’s biggest Internet retailers, including Amazon, Apple, Staples, eBay, and Alibaba, along with dozens of more specialized e-commerce sites like Etsy, Zappos, Netflix, and NewEgg.

But in a recent phone interview, Hollis said the big e-commerce players like Amazon and eBay were founded 20 years ago during the first dot-com boom, and still basically operate only as e-commerce websites.

Holonis is taking a more holistic approach. “What we’ve basically built, in a nutshell, is an ecosystem that empowers global commerce,” Hollis said.

Hollis, who has a stream-of-consciousness way of talking, said: “I would like to think that we’re a more modernized and up-to-date marketplace that takes advantage of search engine optimization, takes advantage of publishing content—photos, videos, and articles—takes advantage of the distribution of that content to social media channels, to e-mail channels, to search engine channels, distributes that information, [and] creates conversations with consumers who are looking for you. Now you’re into customer engagement, and the customer engagement leads to transparency because now the company is producing content and becoming exposed to consumers, and all that transparency and conversation leads to trust, and that trust leads to transactions, and all the transactions lead to data.”

Hollis plans to make money by renting space in its online marketplace to small and medium-size businesses, and by providing them with access to Holonis’ suite of software and back-office services.

Hollis, 62, said he started Holonis in March 2009, immediately after he was ousted from San Diego’s Hollis-Eden Pharmaceuticals, the biopharmaceutical startup he founded in 1992 and where he served as chairman and CEO for over 17 years.

Hollis-Eden was focused on … Next Page »

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Cebix Shuts Down Following Mid-Stage Trial of C-Peptide Drug

Mon, 02/23/2015 - 09:40
Bruce V. Bigelow

San Diego-based Cebix, which raised about $50 million to advance a C-peptide replacement therapy for treating diabetes-related microvascular problems, has quietly folded its tent.

Jacob Fuchs, an Xconomy reader and pharmacy student interested in the use of C-peptide as a potential treatment for diabetic patients, recently inquired about the company’s status. In an e-mail, he noted that the company’s website had shut down and their phone numbers are disconnected. “It’s like they fell off the face of the Earth or something,” he wrote.

When I asked for an update from Cebix CEO Joel Martin, he replied, “Falling off the face of the Earth is pretty close!”

Cebix, founded in 2008, was based on a promising hypothesis. John Wahren, an emeritus professor of clinical physiology at Sweden’s Karolinska Institute, had helped determine that C-peptide plays a key role in keeping the smallest blood vessels healthy.

C-peptide is formed naturally in the body, when insulin is cleaved from pro-insulin. Patients with type 1 diabetes, whose pancreases produce little or no insulin, are also susceptible to microvascular deterioration, including loss of sensation (neuropathy), loss of kidney function (nephropathy), and loss of vision (retinopathy).

Cebix was focused on a proprietary replacement peptide, called Ersatta, for treating such complications.

“We concluded a perfectly executed phase 2b in December, just to get definitive results that Ersatta and placebo were, alas, indistinguishable,” Martin explained. “We determined that there was no point in further development and moved to wind down operations. As efficient as ever, we did that in 30 days.”

In October, 2012, Cebix raised $30.9 million to fund the mid-stage trial. At that time, Martin said the company had raised a total of nearly $48 million, primarily from InterWest, Sofinnova Ventures, and Thomas, McNerney & Partners.

In a regulatory filing last November, Cebix disclosed that it had secured nearly $32 million in additional commitments from its investors for a planned $34.9 million round, apparently in anticipation of capital the company would need to move Ersatta into late-stage clinical trials. After getting the lackluster results in December, the company instead shut down.

“The team and I are looking at many NewCo ideas with the support of our investors,” Martin wrote. “We can only control the operations, not the outcomes. We’ll be back in another guise before you know it!”

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Angel Groups Seek to Assure Entrepreneurs They Are Accredited

Mon, 02/23/2015 - 09:20
Benjamin Romano

The angel investing horror story goes something like this: An entrepreneur publicly solicits seed capital under new securities laws, but accidentally accepts investment from an unaccredited investor. When this violation of JOBS Act rules is discovered, the entire investment round must be rolled back and the money—if there’s any left—returned. It’s the ultimate lose-lose situation.

“Everything shuts down and everyone loses money,” says Yi-Jian Ngo, managing director of the Alliance of Angels, a long-tenured angel group in Seattle.

It almost doesn’t matter whether this has actually happened under new rules born of the 2012 JOBS (Jumpstart Our Business Startups) Act, which lifted the longtime ban on general solicitation of securities offerings by small companies, provided the companies verify that all investors are accredited. The fear that it could, along with continuing uncertainty, has caused some entrepreneurs and investors to avoid generally solicited deals altogether. (It had been illegal since 1933 to advertise a non-registered stock offering to the general public. Until the JOBS Act, small companies selling equity did so privately, through quiet offerings in which shares were sold only to accredited investors with whom the company had a pre-existing relationship.)

This caution can also be seen at startup accelerators such as Techstars, which have dialed-down the specific financial details presented on stage at their demo days and even explored new company presentation models to ensure they don’t accidentally generally solicit investment.

Now some angel investing groups are taking steps to clear away some of the ongoing JOBS Act confusion, and remove the costly burden from startup entrepreneurs of verifying that all of their investors are indeed accredited.

The Alliance of Angels is among about 15 groups to have the Established Angel Group Certification from the Angel Capital Association (ACA), a national nonprofit trade organization based in Overland Park, KS. The certification essentially provides a company seeking investment verification that all the investors in the angel group are accredited, meaning—for now, anyway—they have net worth in excess of $1 million or annual income of at least $200,000 (or $300,000 for married couples).

Other groups to receive the certification so far include Hub Angels Investment Group of Cambridge, MA; Launchpad Venture Group in Boston; the Bellingham Angel Investors in Bellingham, WA; and the Tech Coast Angels, with various locations in Southern California.

The ACA issues the certification to groups that are established with the purpose of early-stage investment; have a code of conduct; include processes to allow individual members to invest their own money or participate in the group’s investment decisions; regularly require members to self-certify that they are accredited and aware that angel investing is risky; and vet new members thoroughly.

While the Securities and Exchange Commission hasn’t made an official pronouncement on the certification, it is in keeping with guidance that SEC officials have intimated, says Marianne Hudson, executive director of the ACA. Keith Higgins, who heads the SEC’s corporate finance division, speaking for himself at an ACA event last year, “essentially endorsed” the certification, she says. In the speech, which is posted in its entirely online, Higgins described a “principles-based approach” in which companies issuing stock can look at “the particular facts and circumstances to determine the steps that would be reasonable to verify that someone is indeed an accredited investor,” and that reliable third-parties could undertake this verification.

Angel investing remains a relationship-based endeavor. New investors are frequently invited in by business and social acquaintances (though that too is starting to change with efforts such as Seattle Angel Conference and The Lion’s Den casting a wider net for would-be investors).

That social aspect is a big part of what makes the EAG Certification work, proponents say. “It’s very unusual to join [the Alliance of Angels] without any references, without any kind of background,” Ngo says. “So in most cases, when someone applies, chances are we would know someone who’s connected to that person and we would be able to tell fairly quickly whether or not this is really someone who’s accredited.”

The EAG Certification will also be a competitive differentiator, Ngo says, as angel groups jockey for deal flow in a marketplace where entrepreneurs—particularly the best of them—have more options for raising early capital, including crowdfunding platforms, startup competitions, and proliferating angel groups.

It’s worth stepping back for a moment to remember why lifting the ban on general solicitation—in place for more than eight decades—was significant in the first place, and how we ended up with Rule 506(c) of Regulation D of the Securities Act of 1933. There was … Next Page »

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Innovation Hub: Meet the Science Evangelist

Fri, 02/20/2015 - 16:58
Kara Miller

Ainissa Ramirez says she’s a “Science Evangelist,” and she travels the country to preach her gospel in classrooms.

As a result, the former Yale professor hopes to invigorate students, amping up their engagement with everything from nanotech to material science. I talked to her about how you help a generation of kids find their inner scientist.

[This interview has been edited and condensed. For the full conversation, visit innovationhub.org.]

Kara Miller: You’re tackling a problem that we come back to again and again: how do you get more people interested in science and create classes and labs that look more like America? So from your perspective, how do you diagnose the current problem?

Ainissa Ramirez: We have a lot of people who want to take STEM classes, but they pretty much get obliterated with weed-out classes—introduction to science classes, introduction to math classes. We have a long legacy of teaching these classes in hopes of weeding out the students who aren’t too sure of themselves. That’s the way it was set up, because there weren’t many opportunities. But that’s not the case anymore. So we have to update this tradition to where we are as a nation. We need to change the way we teach those courses.

KM: Does that mean making science classes a ton more fun? Does it mean taking some of the more complicated math out of science classes? What does that new science class look like?

AR: I think that it should be more fun, and it should be relevant. I like to show the kids all the cool things that happen with nanotechnology. I tell them that if I were to get one of my hairs and whittle it 100,000 times, one of those slivers would be a nanometer. And then I explain that gold is yellow, but if I was to collect 80 gold atoms and put them together, it’s not gold anymore. It turns out to be red. And all the kids are amazed. Now that I’ve hooked their attention, I can talk about why we have these strange effects, and where these things are going to be used. I’ll tell them that one of the places that they’ll be used is to help cure cancer, and that usually gets their attention.

KM: What are you personally doing to get more people into STEM classes, so it’s not just the elite, geeky few?

AR: I spend a lot of time going to different schools and talking to students about science. And I show them new technology like nanotechnology. But I don’t hit them really hard with math because that’s not going to attract them.

KM: What is your end goal?

AR: My end goal is to be out of a job. I want to be in a world where people are not afraid to ask why about how things are made. I want people to get back in touch with their inner scientist and be curious. It’s a lofty goal, but we were there when we were young. I want us to go back to being inquisitive again.

Tricia Breton contributed to this write-up.

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WHO Approves 15-Minute Ebola Test Developed by Corgenix

Fri, 02/20/2015 - 15:38
Michael Davidson

Doctors who continue to battle the Ebola epidemic that rages on in Africa—even if it’s once again out of the headlines in the U.S.—might be getting a new tool thanks to Corgenix, a medical test maker based outside Denver. On Thursday, the World Health Organization approved Corgenix’s blood test that can diagnose Ebola victims within 15 minutes.

Corgenix’s ReEBOV Antigen Rapid Test successfully identified Ebola in about 92 percent of people with the disease, and it was 85 percent effective at screening out people who were not infected, according to the WHO. That’s not as successful as conventional tests, but it is much faster. With the standard tests, doctors have to wait up to 24 hours before getting results from a laboratory.

The WHO said that was valuable enough to outweigh its comparative inaccuracy.

“While less accurate, the antigen test is rapid, easy to perform and does not require electricity—it can therefore be used at lower health care facilities or in mobile units for patients in remote settings,” the organization said in a release. It recommends that patients then undergo a standard test to confirm the result.

The test was evaluated under the organization’s Emergency Assessment and Use program, which was established to provide minimum quality, safety, and performance assurance for diagnostic products in the context of the Ebola emergency.

Standard Ebola tests search the virus’s genetic material, specifically nucleic acids. The Corgenix test searches for an Ebola protein.

A British virologist said the test “is not a gamechanger, but it is another useful tool.”

“The new test could help to quickly confirm outbreaks in remote areas without the need to send samples to a testing clinic and wait for results,” University of Reading virologist Ben Neuman said. “The new test isn’t about saving the lives of infected people, but it can help in the long run by making it easier and quicker to detect Ebola outbreaks.”

Corgenix (OTC: CONX) is located in Broomfield, CO, and before developing its Ebola test it focused on diagnostics for vascular and liver diseases. The company has received a number of grants to develop the Ebola test, including a $2.9 million grant from the National Institutes of Health and two grants totaling $818,000 from the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation.

The success of the new Ebola test comes despite some rocky times for the company. Early last year Corgenix announced it was looking for a buyer. It found one in Orgentec, a German company, which in August agreed to buy Corgenix for about $16 million. The deal was held up following a lawsuit from some Corgenix shareholders, but the suit has been dropped and the deal is expected to close this quarter.

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Seragon CEO Rich Heyman Is Going on Hiatus

Fri, 02/20/2015 - 02:01
Bruce V. Bigelow

The moving boxes are stacked in the hallways of San Diego’s Seragon Pharmaceuticals, and that means the end is near for CEO Rich Heyman.

He’s fine with that. As Heyman put it, “I’m not going to go operational any time soon.”

After selling Seragon to Genentech, the South San Francisco-based unit of Roche, last July in a deal valued at more than $1.7 billion, Heyman has been overseeing the shutdown of Seragon’s operations in San Diego’s suburban Del Mar Heights. “We’ve done everything we said we were going to do,” Heyman said one recent morning in Seragon’s third-floor conference room. “It’s still a little bittersweet.”

As I reported last summer, Heyman is the guy who made lightning strike twice in the same place. Before selling Seragon, he was the founding CEO of its predecessor company, Aragon Pharmaceuticals, which was acquired by Johnson and Johnson for $1 billion in 2013. Heyman, an expert in endocrinology and hormone signaling, said it was clear from the beginning that if his team could find a way to successfully block the androgen-related receptors in hormone-driven prostate cancer, they could also find a similar way to block hormone-driven breast cancer.

As part of the deal with Genentech, Heyman agreed to oversee the transition, which included the transfer of key biological, clinical, and regulatory assets from San Diego to South San Francisco.  Genentech got Seragon’s entire portfolio of potential oral drug compounds,  known as selective estrogen receptor degraders (SERDs).

But now Seragon has to vacate its offices before the end of the month. After that, Heyman will be out of a job.

After announcing the deal with Genentech last summer, Heyman said, “Almost immediately, people started calling to ask, ‘Do you want to join a new company? Do you want a board seat? Do you want to be a venture partner?’”

He sought the counsel of four friends with similar experience: Carol Gallagher sold Seattle-based Calistoga Pharmaceuticals in 2011; Bob Baltera sold San Diego’s Amira Pharmaceuticals that same year; Tony Coles sold Onyx Pharmaceuticals in 2013; and Faheem Hasnain, a biotech veteran and board member at both Aragon and Seragon.

Heyman said he asked them, “Did you take time off? What did you think about?”

Gallagher, Baltera, and Coles all took substantial time off, and that’s what Heyman wants to do too.

Heyman says he loves science, and he wants to maintain that perspective as he contemplates his next move. As a result, he has joined the boards at the UC San Diego Moores Cancer Center and the Salk Institute, where he once worked with Ron Evans to identify hormone receptors.

“I want the quality time to think about what I want to do next,” Heyman said. “We all run so hard and so fast that we often don’t have the time to think deeply, or have a little reflectance.”

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